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复星医药(02196.HK)拟就HLX04与亿胜投资及珠海亿胜进行开发合作
格隆汇 10-15 16:25

格隆汇10月15日丨复星医药(02196.HK)公告,上海复星医药(集团)股份有限公司(以下简称“公司”)控股子公司上海复宏汉霖生物技术股份有限公司(以下简称“复宏汉霖”)拟就HLX04(即重组抗VEGF人源化单克隆抗体注射液,以下简称“该新药”)用于湿性年龄相关性黄斑变性等眼病治疗与EssexBio-InvestmentLimited(以下简称“亿胜投资”)、珠海亿胜生物制药有限公司(以下简称“珠海亿胜”)(亿胜投资与珠海亿胜以下合并简称“Essex”)进行开发合作,并于区域内(即全球范围,下同)及领域内(即眼科治疗领域,下同)就该新药授予Essex注册、生产及商业化(包括但不限于出口、进口、推广、储存、要约出售及分销等商业化行为)的独家许可等(以下简称“本次合作”)。

该新药为集团(即本公司及控股子公司/单位,下同)自主研发的贝伐珠单克隆抗体生物药,拟主要用于湿性年龄相关性黄斑变性、糖尿病性视网膜病变、转移性结直肠癌和非小细胞肺癌等适应症的治疗。截至2020年9月,集团现阶段针对该新药累计研发投入约为人民币47,781万元(未经审计)。

截至公告日,该新药用于湿性年龄相关性黄斑变性和糖尿病性视网膜病变适应症治疗已获国家药监局临床试验批准,该新药用于转移性结直肠癌及晚期、转移性或复发性非小细胞肺癌治疗已获国家药监局药品注册审评受理。截至本公告日,该新药用于眼科适应症治疗在其他国家或地区尚未获得相关监管机构的临床试验批准。

亿胜投资成立于2000年,注册地为英属维尔京群岛,董事长为严贤龙。珠海亿胜成立于1999年,注册地为中国广东省,董事长为郑赞顺。亿胜投资、珠海亿胜均为亿胜生物科技有限公司(于香港联合交易所有限公司上市,证券代码为“01061”,以下简称“亿胜生物科技”)的控股子公司,亿胜生物科技主要专注投资控股,以及开发、制造及销售生物药品。

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